MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-12 for COBAS 501E CEE (C501) 05061482190 manufactured by Roche Diagnostics Gmbh.
[5880638]
Beginning with the start up in the am for midnight shift, we started having qc issues with calciums on the ce to the point we could not get the qc to work at all. Roche hotline was contacted and multiple procedures (cleans, flushes, recal's, reagent dumps, etc. ) were tried. Nothing fixed it. When day shift attempted their start up on the other analyzer (cee), we experienced the same issue. When we called service, we were told that the water coming into the analyzers could be a potential cause for the problem. Service did come in and dumped and cleaned the water bath on the cee, and checked for anything on the instrument that could have caused the issue. But with the problem occurring on both analyzers, we felt strongly it was the water that had caused the problems. We had to dump all calcium packs that had been loaded during that time, as they all had used water for diluting reagents. By the end of day, we were finally able to get qc to work and start reporting pts again.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4780577 |
| MDR Report Key | 4780577 |
| Date Received | 2015-05-12 |
| Date of Report | 2015-05-11 |
| Date of Event | 2015-05-06 |
| Report Date | 2015-05-11 |
| Date Reported to FDA | 2015-05-12 |
| Date Reported to Mfgr | 2015-05-19 |
| Date Added to Maude | 2015-05-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 501E |
| Generic Name | TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM |
| Product Code | JFP |
| Date Received | 2015-05-12 |
| Model Number | CEE (C501) |
| Catalog Number | 05061482190 |
| Lot Number | 609429 |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 5 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Address | 9115 HAGUE ROAD INDIANAPOLIS IN 46250 US 46250 |
| Brand Name | ELIX |
| Generic Name | PURIFIER, WATER (ABSORPTION, DEIONIZATION, MEMBRANE FILTER, |
| Product Code | FIP |
| Date Received | 2015-05-12 |
| Model Number | ELIX 100 (CUSTOM) |
| Catalog Number | PROGTLOS1US |
| Lot Number | F3MA66536 |
| ID Number | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | EMD MILLIPORE CORPORATION |
| Manufacturer Address | 290 CONCORD ROAD BILLERICA MA 01821 US 01821 |
| Brand Name | ELIX |
| Generic Name | PURIFIER, WATER (ABSORPTION, DEIONIZATION, MEMBRANE FILTER, |
| Product Code | FIR |
| Date Received | 2015-05-12 |
| Model Number | ELIX 100 (CUSTOM) |
| Catalog Number | PROGTLOS1US |
| Lot Number | F3MA66536 |
| ID Number | * |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | EMD MILLIPORE CORPORATION |
| Manufacturer Address | 290 CONCORD ROAD BILLERICA MA 01821 US 01821 |
| Brand Name | COBAS 501E |
| Generic Name | TITRIMETRIC WITH EDTA AND INDICATOR, CALCIUM |
| Product Code | JFP |
| Date Received | 2015-05-12 |
| Model Number | CE (C501) |
| Catalog Number | 05061482190 |
| Lot Number | 609429 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 5 MO |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Address | 9115 HAGUE ROAD INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-12 |